NCT04793217Completed
A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
Project Someleze: A Randomized Trial of ImpACT+, a Coping Intervention to Improve Clinical and Mental Health Outcomes Among HIV-infected Women With Sexual Trauma in South Africa
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 350 (actual)
- First submitted
- 9 Mar 2021
- Start date
- 18 Feb 2021
- Primary completion date
- 3 Jul 2025
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT04793217
What you commit to
- Study type: Interventional
- Participants enrolled: 350
- From 18 Feb 2021 to the primary completion date, 3 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- High suicide risk
Who the study is looking for
- Women with HIV who receive care at either study clinic
- \>2 weeks to \<4 months since ART initiation
- History of sexual trauma
- Meets criteria for traumatic stress
- Xhosa speaking
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cape Town Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.